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e-CFR data is current as of August 13, 2020

Title 21Chapter ISubchapter JPart 1002Subpart B → §1002.13


Title 21: Food and Drugs
PART 1002—RECORDS AND REPORTS
Subpart B—Required Manufacturers' Reports for Listed Electronic Products


§1002.13   Annual reports.

(a) Every manufacturer of products requiring an annual report as specified in table 1 of §1002.1 shall submit an annual report summarizing the contents of the records required to be maintained by §1002.30(a) and providing the volume of products produced, sold, or installed.

(b) Reports are due annually by September 1. Such reports shall cover the 12-month period ending on June 30 preceding the due date of the report.

(c) New models of a model family that do not involve changes in radiation emission or requirements of a performance standard do not require supplemental reports prior to introduction into commerce. These model numbers should be reported in quarterly updates to the annual report.

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